Unique ID issued by UMIN | UMIN000006823 |
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Receipt number | R000008068 |
Scientific Title | Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY) |
Date of disclosure of the study information | 2011/12/03 |
Last modified on | 2023/09/01 16:54:32 |
Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)
Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)
Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)
Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)
Japan |
Colorectal Cancer
Gastrointestinal surgery |
Malignancy
YES
To evaluate efficacy and safety of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatn-based chemoterapy without CV port.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Response rate
Disease control rate
Progression free survival
Overall survival
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Irinotecan plus S-1 (IRSI) with biweekly cetuximab combination therapy
1)Irinotecan 100 mg/m2 day1,15, 30 biweekly until PD
2)S-1 80mg [BSA<1.25m2] or 100mg [1.25m2<BSA<1.5m2] or 120mg [1.5m2<BSA]/body/day, day 1-14, q4weeks
3)Cetuximab 500mg/m2 day 1, 15, 29 biweekly until PD
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically confirmed colorectal cancer.
2) Clinically proven unresectable advanced / metastatic colorectal cancer
3) Previously received on one regimen of oxaliplatin-contained chemotherapy (contained relapse less than 6 months from adjuvant chemotherapy)
4) Presence of at least one measurable lesion (according to the RECIST ver.1.1)
5) Immunohistochemical evidence of EGFR expression, either in the primary tumor or in metastatic tumor lesion
6) KRAS wild type (in codon 12, 13) confirmed, either in the primary tumor or in metastatic tumor lesion
7) Patients unaffected prior therapy
At least 4-6 weeks since prior radiotherapy
At least 4 weeks since prior operation for organ
At least 2 weeks since prior chemotherapy
At least 2 weeks since prior immune therapy, cytokine therapy or BRM therapy
8) More than 20 years of age
9) ECOG performance status 0-1
10) Adequate organ function for study treatment
WBC>=3,000mm3, neutrophils>=1,000/mm3
Platelets>=100,000/mm3
Hemoglobin>=9.0g/dl
AST and ALT<=upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis)
Total bilirubin<=upper limit of normal (ULN)*2
Creatinine<=1.5mg/dl
11) Oral food intake possible
12) Life expectancy must be 3 months or longer after the combination therapy
13) Written informed consen+C120t
1) History of severe allergy
2) Simultaneous or metachronous double cancers
3) Symptomatic brain metastasis
4) Severe infectious disease
5) Severe complications (interstitial lung disease or pulmonary fibrosis, heart failure, kidney failure, hepatic failure, uncontrolable diabetes, Jaundice)
6) Paralytic or mechanical bowel obstruction
7) Massive pleural effusion or ascites
8) Wattery diarrhea
9) Patients who is receiving Atazanavir Sulfate or Flucytosine
10) Pregnant or lactating women or women of childbearing potential
11) Any other cases who are regarded as inadequate for study enrollment by the investigator.
30
1st name | |
Middle name | |
Last name | Yoichiro Yoshida |
Fukuoka University Faculty of Medicine
Department of Gastroenterological Surgery
7-45-1,Nanakuma,Johnan-ku,Fukuoka ,814-0180,Japan
1st name | |
Middle name | |
Last name | Yoichiro Yoshida |
Fukuoka University Faculty of Medicine
Gastroenterological Surgery
7-45-1,Nanakuma,Johnan-ku,Fukuoka ,814-0180,Japan
Fukuoka Tumor Research(FUTURE)
None
Self funding
NO
福岡大学医学部消化器外科学
2011 | Year | 12 | Month | 03 | Day |
Unpublished
Terminated
2011 | Year | 06 | Month | 28 | Day |
2011 | Year | 11 | Month | 15 | Day |
2011 | Year | 12 | Month | 01 | Day |
2013 | Year | 12 | Month | 31 | Day |
2011 | Year | 12 | Month | 03 | Day |
2023 | Year | 09 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008068
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